Note: The job is a remote job and is open to candidates in USA. Evolution Research Group is a clinical research organization seeking a Project Manager to lead clinical study operations. The role manages project scope, budgets, timelines, teams, vendors, regulatory compliance, study documents, and communications with sponsors, sites, and internal stakeholders.
Responsibilities
- Assume primary accountability for assigned clinical research projects and ensure compliance with applicable regulations, guidelines, and corporate policies for study activities
- Manage and execute the overall project scope, budget, and timelines. Identify project success factors for analysis, reporting, and tracking
- Manage resources and timelines associated with all study start-up and implementation activities, including CRO/investigator agreements, and contractual agreements
- Lead the development of study specific protocols, consent forms, and other trial related materials as required
- Ensure the appropriate development of study documents including, but not limited to, study plans, case report form instructions, site selection materials, investigator updates, and other project-specific documents required for the conduct of assigned studies
- Participate in the review of clinical data for analysis
- Ensure that all project tasks meet client expectations and are completed in accordance with the contract, trial protocol, and Standard Operating Procedures (SOPs)
- Serve as a liaison between clients and internal team to ensure project specific information and ongoing updates are proactively communicated
- Plan for and manage all materials to support the appropriate execution of the clinical projects, including but not limited to distribution of documents, forms, supplies, equipment, and investigational device. Monitor adherence to project contract and budget
- Coordinate with clinical, marketing, and operations management to identify goals and scope of clinical study projects. Ensure operational and regulatory integrity of assigned studies and participate in FDA or other regulatory authority inspections, as needed
- Support the management and oversight of clinical study related vendors. Review site monitoring reports ensuring finalization as required by SOP and/or client contractual requirements
- Provide therapeutic training and guidance to clinical team
- Enhance department and organization reputation by participating in departmental or corporate initiatives
- Update job knowledge by participating in educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations
- Attending off-site meetings and conferences, as needed
- Perform other miscellaneous related duties, as required
Skills
- The Project Manager is a proven leader in clinical program management in the clinical research industry
- Bachelor's degree or equivalent education/degree in life science/healthcare is required accompanied by 5 years of working within clinical project management at a local medical organization, investigational site, pharmaceutical company, CRO, or clinical fellowship program
- Experience qualifying & managing external vendors
- Experience leading project operational teams through the start-up, study conduct, data management, and report writing of clinical studies
- Experience writing, reviewing, and editing protocols and clinical study reports as well as working knowledge of the FDA submission process
- Ability to facilitate a teamwork philosophy with a positive attitude
- Extensive organizing and coordinating skills, teaching and facilitation skills, ability to assess training needs and objectives
- Extensive experience overseeing and coordinating the work of others
- Ability to work effectively and efficiently handling multiple tasks simultaneously
- Ability to exercise judgment and determine appropriate action to a variety of problems of varying complexity
- Ability to manage multiple deadlines
- Must have a ‘can-do' attitude and a strong desire to take ownership of many different projects
- Strong computer skills, including Microsoft Office
- CRO experience is highly desirable
Benefits
- Remote work arrangement
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